ASTEK Polska jest częścią dynamicznie rozwijającej się międzynarodowej Grupy ASTEK. Specjalizujemy się w outsourcingu kadry IT i realizacji projektów informatycznych. Zatrudniamy doświadczonych specjalistów dla liderów z obszarów bankowości, ubezpieczeń, telekomunikacji, hi-tech, farmacji i logistyki w Polsce i za granicą.
Validation Lead
Currently we are looking for Validation Lead Location: 100% remote Salary: up to 100 zł/h B2B Start: ASAP Allocation: Q1/Q22021: 0,75 FTE Q3/Q42021: 0,5 FTE
Responsibilities:
Determines validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerised systems
Responsible for the review of software documentation according to CSV corporate SOPs, and regulatory guidance
Provide estimates and forecast validation activities for a project
Author validation plans/reports, reviews test plans/reports (and other deliverables) to asses and notify that system is ready to go life
Verification of testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions
Requirements:
3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment
Experience in leading validation for projects and systems maintenance
Experience in authoring validation plans, reports and deliverable registries
Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11
Communication skills, English language mandatory (C1)
